This sample statement of work is being provided as an aid to medical device and healthcare product manufacturers for the purpose of improving the effectiveness and compliance of their temporary labor procurement process. In our world of compliance and risk management, supplier management is garnering much more focus and attention, especially in relation to the pending 2016 update to ISO 13485. This template has been vetted by veteran medtech procurement managers and should provide a good launch point for any company’s journey into this very important area of risk mitigation.

Food & Drug Administration

As a regulated industry, the Healthcare Industry has many compliance rules and regulations.
Through these educational videos and regulation documents Operon hopes to make
the journey a little bit easier for you.

International Standards Sources

Certifications to the International Organization for Standardization (ISO) have become the de facto tool for
organizations to communicate their practices & cultures to the world. Below, Operon has provided some quick
links to the most commonly applied documents and guidance tools for the Healthcare industry.